FDA Inspection
Earthley WellnessEarthley Wellness – FDA Inspection, Sep 5, 2025
Record Details
This FDA Inspection record concerns Earthley Wellness, with an inspection on September 5, 2025, issued by the Cincinnati District Office, covering foods & cosmetics.
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ID · e37ad595-7856-4ca9-9699-bc0344a70167
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1280669
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling, and Economics
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 111.315(b)Sampling plans; establish, follow
- 21 CFR 111.160(e)Labels - contamination, deterioration, mix-up
- 21 CFR 111.75(a)(2)(ii)(C)Documentation - qualify supplier
- 21 CFR 111.165(b)Physical plant - clean and sanitary
- 21 CFR 111.455(c)Hold - mix-up, contamination, deterioration
- 21 CFR 111.260Batch record - required information
- 21 CFR 111.210Master manufacturing record - record requirements
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